Data / Medical devices / Catheter, Angioplasty, Peripheral, Transluminal / United States
FDA-registered makers of Catheter, Angioplasty, Peripheral, Transluminal in the United States: 27 establishments
27 establishments in the United States are registered with the FDA to make Catheter, Angioplasty, Peripheral, Transluminal (product code LIT). 21 have a 510(k) clearance or PMA approval on file and 11 have a recall event. FDA data exported November 3, 2026.
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- Device
- Catheter, Angioplasty, Peripheral, Transluminal
- Product code
- LIT
- Country
- United States
Makers of Catheter, Angioplasty, Peripheral, Transluminal in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Specification developer | 14 | July 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer, Manufacturer for export | 14 | July 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| ev3, Inc. | Plymouth, MN, United States | Manufacturer, Specification developer | 14 | December 15, 2021 | 0 | 2 | 0 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Specification developer | 8 | January 20, 2023 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer, Manufacturer for export, Specification developer | 7 | July 10, 2024 | 0 | 4 | 0 | api.fda.gov |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 7 | August 22, 2022 | 0 | 6 | 0 | api.fda.gov |
| Abbott Vascular | Temecula, CA, United States | Complaint file establishment, Manufacturer | 6 | February 13, 2026 | 0 | 2 | 0 | api.fda.gov |
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 5 | February 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Numed, Inc. | Hopkinton, NY, United States | Manufacturer | 5 | December 1, 2000 | 0 | 1 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 3 | February 13, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Vascular | Danvers, MA, United States | Specification developer | 3 | March 29, 1994 | 0 | 1 | 1 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 3 | March 30, 2017 | 0 | 0 | 0 | api.fda.gov |
| Verge Medical Inc. | Campbell, CA, United States | Complaint file establishment, Specification developer | 3 | May 8, 2015 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 2 | September 15, 2020 | 0 | 1 | 0 | api.fda.gov |
| Contego Medical, Inc | Raleigh, NC, United States | Complaint file establishment, Specification developer | 2 | June 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 2 | March 30, 2017 | 0 | 2 | 0 | api.fda.gov |
| Summa Therapeutics, LLC | Allston, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | July 16, 2024 | 0 | 1 | 0 | api.fda.gov |
| Curatia Medical Co. | Sunnyvale, CA, United States | Specification developer | 1 | July 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Micro Medical Solutions Inc | Woburn, MA, United States | Manufacturer | 1 | April 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries (NAMIC Division) - Glen Falls | Glens Falls, NY, United States | Manufacturer, Repackager or relabeler | 1 | September 27, 1990 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Roseville, CA, United States | Manufacturer | 1 | January 15, 2010 | 0 | 0 | 0 | api.fda.gov |
| Biomerics Fmi | Athens, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnesota Medtec, Inc. | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Springboard Manufacturing | Rancho Cordova, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics U.S., LLC | Queensbury, NY, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synergy Health AST, LLC | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.